Identity
- Trade Name
- KabiHelp Uno EUDAMED
- Device Name
- Parenteral Bags EUDAMED
- Model / Reference
- F1320ACCK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 28058159784308 EUDAMED
- Basic UDI-DI
- 805815978SPYV EUDAMED
- Unit of Use DI
- 18058159784301 EUDAMED
- EMDN Code
- A080102 PARENTERAL FEEDING BAGS AND CONTAINERS (INCLUDING THOSE VIA PUMP), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Intravenous administration bag/bottle
KabiHelp Uno by DIFFUPLAST srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805815978SPYV | Class I | Active |
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Manufacturer
- Manufacturer
- DIFFUPLAST srl
- EUDAMED SRN
- IT-MF-000022506
Sources (1)
- EUDAMED 5deaf11f-1689-4d1a-b469-c3c0008db99b 61 fields · synced Jul 13, 2026